Evidence map›Paper›PMID 24840400›Full record

Observational studySurgery today2014

Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery: a multicenter study.

Taishi Hata, Masayoshi Yasui, Kohei Murata, Masaki Okuyama, Masayuki Ohue, Masataka Ikeda, Shigeyuki Ueshima, Kotaro Kitani, Junichi Hasegawa, Hiroshi Tamagawa and 11 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Surgery today, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Taishi HataDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Masayoshi Yasui
Kohei Murata
Masaki Okuyama
Masayuki Ohue
Masataka Ikeda
Shigeyuki Ueshima
Kotaro Kitani
Junichi Hasegawa
Hiroshi Tamagawa
Makoto Fujii
Atsushi Ohkawa
Takeshi Kato
Shunji Morita
Takayuki Fukuzaki
Tsunekazu Mizushima
Mitsugu Sekimoto
Riichiro Nezu
Yuichiro Doki
Masaki Mori
Multi-Center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis in Japanese patients undergoing colorectal cancer surgery.

methodsThe subjects of this multicenter, open-label, prospective observational study were patients undergoing resection of the colon/rectum for colorectal cancer. All patients were given FPX 2.5 or 1.5 mg by subcutaneous injection, once daily for 4-8 days, starting 24 h after surgery. The primary endpoint was any major bleeding event and the secondary endpoint was any symptomatic VTE event.

resultsBetween February 2009 and December 2010, 619 patients from 23 institutions were enrolled in this study. The median duration of FPX prophylaxis was 4 days. The incidence of major bleeding was 0.81 % [5/619, 95 % confidence interval (CI) 0.3-1.9] and the incidence of minor bleeding was 9.5 % (59/619, 95 % CI 7.3-12.1). There was no fatal bleeding or symptomatic VTE. Multivariable analysis revealed the following to be risk factors for bleeding events: preoperative platelet count <15 × 10(4)/µl [odds ratio (OR) 4.521], male sex (OR 2.078), and blood loss during surgery <50 ml (OR 2.019).

conclusionThe administration of 2.5/1.5 mg FPX 24 h after colorectal cancer surgery is safe and effective.

Indexed as

AgedAnticoagulantsAsian PeopleColorectal NeoplasmsFemaleFondaparinuxHumansInjections, SubcutaneousMaleMiddle AgedPolysaccharidesPostoperative ComplicationsPremedicationProspective StudiesSafetyTime FactorsAnticoagulantsFondaparinuxPolysaccharides

Identifiers

PMID24840400
PMCPMC4194009

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.